84696 Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations 

Using Agency. U.S. Marine Corps, 

Commanding Officer, Marine Corps Air 

Station Yuma, Yuma, AZ. 

* * * * * 

Issued in Washington, DC, on November 

30, 2023. 

Karen Chiodini, 

Acting Manager, Rules and Regulations 

Group. 

[FR Doc. 2023–26706 Filed 12–5–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 516, 520, 522, 524, 

and 558 

[Docket No. FDA–2023–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Withdrawal 

of Approval of New Animal Drug 

Applications; Change of Sponsor; 

Change of Sponsor Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending the animal drug regulations to 

reflect application-related actions for 

new animal drug applications (NADAs), 

abbreviated new animal drug 

applications (ANADAs), and 

conditionally approved new animal 

drug applications (CNADAs) during 

July, August, and September 2023. The 

animal drug regulations are also being 

amended to improve their accuracy and 

readability. 

DATES: This rule is effective December 6, 

2023. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–5689, 

George.Haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Approvals 

FDA is amending the animal drug 

regulations to reflect approval actions 

for NADAs, ANADAs, and CNADAs 

during July, August, and September 

2023, as listed in table 1. In addition, 

FDA is informing the public of the 

availability, where applicable, of 

documentation of environmental review 

required under the National 

Environmental Policy Act (NEPA) and, 

for actions requiring review of safety or 

effectiveness data, summaries of the 

basis of approval (FOIA Summaries) 

under the Freedom of Information Act 

(FOIA). These documents, along with 

marketing exclusivity and patent 

information, may be obtained at 

AnimalDrugs@FDA: https://

animaldrugsatfda.fda.gov/adafda/ 

views/#/search. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING JULY, AUGUST, AND

SEPTEMBER 2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS

Approval date File No. Sponsor Product name Effect of the action 21 CFR 

section 

July 6, 2023 ................ 200–752 Cronus Pharma Specialties India Private 

Ltd., Sy No-99/1, M/ 

s GMR Hyderabad 

Aviation SEZ Ltd., 

Mamidipalli Village, 

Shamshabad 

Mandal, Ranga 

Reddy, Hyderabad, 

Telangana, 501218, 

India.

DEXMEDVET 

(dexmedetomidine 

hydrochloride) 

Injectable Solution.

Original approval as a sedative, 

analgesic, and preanesthetic in 

dogs and cats as a generic 

copy of NADA 141–267.

522.558 

July 11, 2023 .............. 200–753 Do ............................... CROPAMEZOLE 

(atipamezole hydrochloride) Injectable 

Solution.

Original approval for reversal of 

sedation and analgesia in dogs 

as a generic copy of NADA 

141–033.

522.147 

July 19, 2023 .............. 141–554 Boehringer Ingelheim 

Animal Health USA, 

Inc., 3239 Satellite 

Blvd., Duluth, 

GA30096.

NEXGARD PLUS 

(afoxolaner, 

moxidectin, and 

pyrantel chewable 

tablets).

Original approval for the prevention, treatment, and control of 

internal and external parasites 

in dogs.

520.35 

August 3, 2023 ........... 200–755 Felix Pharmaceuticals 

Pvt. Ltd., 25–28 

North Wall Quay, 

Dublin 1, Ireland.

Firocoxib Chewable 

Tablets.

Original approval for the control of 

pain and inflammation associated with osteoarthritis and for 

the control of postoperative 

pain and inflammation associated with soft-tissue and orthopedic surgery as a generic copy 

of NADA 141–230.

520.928 


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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING JULY, AUGUST, AND

SEPTEMBER 2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS—Continued 

Approval date File No. Sponsor Product name Effect of the action 21 CFR 

section 

August 3, 2023 ........... 200–756 Ceva Sante Animale, 

10 Avenue de la 

Ballastie`re, 33500 

Libourne, France.

FIRODYL (firocoxib) 

Chewable Tablets.

Original approval for the control of 

pain and inflammation associated with osteoarthritis and for 

the control of postoperative 

pain and inflammation associated with soft-tissue and orthopedic surgery as a generic copy 

of NADA 141–230.

520.928 

August 10, 2023 ......... 141–568 Boehringer Ingelheim 

Animal Health USA, 

Inc., 3239 Satellite 

Blvd., Duluth, 

GA30096.

SENVELGO 

(velagliflozin oral solution).

Original approval to improve glycemic control in otherwise 

healthy cats with diabetes 

mellitus not previously treated 

with insulin.

520.2654 

August 31, 2023 ......... 200–757 ZyVet Animal Health, 

Inc., 73 Route 31N, 

Pennington, NJ 

08534.

Acepromazine Maleate 

Tablets 

(acepromazine maleate tablets).

Original approval as an aid in 

tranquilization and as a 

preanesthetic agent in dogs as 

a generic copy of NADA 117– 

532.

520.23 

September 6, 2023 ..... 141–578 Genus Lifesciences 

Inc., 700 N Fenwick 

St., Allentown, PA 

18109.

FIDOQUEL–CA1 (phenobarbital tablets).Conditional approval for the control of seizures associated with 

idiopathic epilepsy in dogs.

516.1760 

September 20, 2023 ... 200–310 Parnell Technologies 

Pty. Ltd., Unit 4, 476 

Gardeners Rd., Alexandria, New 

South Wales 2015, 

Australia.

ESTROPLAN 

(cloprostenol injection) Injectable Solution.

Supplemental approval for use 

with gonadorelin to synchronize 

estrous cycles to allow for fixed 

time artificial insemination 

(FTAI) in lactating dairy cows 

as a generic copy of NADA 

113–645.

522.460 

II. Withdrawals of Approval 

Oasmia Pharmaceutical AB, 

Vallongatan 1, Uppsala, 75228 Sweden 

requested that FDA withdraw 

conditional approval of CNADA 141– 

422 for PACCAL VET–CA1 (paclitaxel 

for injection) because the product is no 

longer manufactured or marketed. Also, 

Med-Pharmex, Inc., 2727 Thompson 

Creek Rd., Pomona, CA 91767–1861 

requested that FDA withdraw approval 

of the eight abbreviated applications 

listed in table 2 because the products 

are no longer manufactured or 

marketed. As provided in the regulatory 

text of this document, the animal drug 

regulations are amended to reflect these 

actions. 

TABLE 2—APPLICATIONS FOR WHICH APPROVAL WAS VOLUNTARILY WITHDRAWN DURING JULY, AUGUST, AND

SEPTEMBER 2023 

File No. New animal drug 21 CFR section 

200–190 .................................. GENTORAL (gentamicin sulfate) Concentrate Solution .......................................................... 520.1044a 

200–241 .................................. LINCOSOL (lincomycin hydrochloride) Soluble Powder .......................................................... 520.1263b 

200–245 .................................. DERMA–VET (neomycin sulfate, nystatin, thiostrepton, triamcinolone acetonide) Cream ..... 524.1600a 

200–275 .................................. MEDALONE (triamcinolone acetonide) Cream ........................................................................ 524.2483 

200–289 .................................. NEOSOL–ORAL (neomycin sulfate) Concentrate Solution ..................................................... 520.1484 

200–292 .................................. IVERSOL (ivermectin) Liquid for Horses ................................................................................. 520.1195 

200–299 .................................. IVER–ON (ivermectin) Topical Solution ................................................................................... 524.1193 

200–456 .................................. Dexamethasone Solution ......................................................................................................... 522.540 

III. Change of Sponsor 

The sponsors of the approved 

applications listed in table 3 have 

informed FDA that they have transferred 

ownership of, and all rights and interest 

in, these applications to another 

sponsor. As provided in the regulatory 

text of this document, the animal drug 

regulations are amended to reflect these 

actions. 

TABLE 3—APPLICATIONS FOR WHICH OWNERSHIP WAS TRANSFERRED TO ANOTHER SPONSOR DURING JULY, AUGUST, 

AND SEPTEMBER 2023 

File No. Product name Transferring sponsor New sponsor 21 CFR section 

141–342 ....... ALFAXAN Multidose (alfaxalone) 

injectable solution.

Jurox Pty. Ltd., 85 Gardiner St., 

Rutherford, NSW 2320, Australia.

Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.522.52 


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TABLE 3—APPLICATIONS FOR WHICH OWNERSHIP WAS TRANSFERRED TO ANOTHER SPONSOR DURING JULY, AUGUST, 

AND SEPTEMBER 2023—Continued 

File No. Product name Transferring sponsor New sponsor 21 CFR section 

200–699 ....... Dexmedetomidine hydrochloride 

injection.

Akorn Operating Co. LLC, 5605 

Centerpoint Ct., Suite A, 

Gurnee, IL 60031.

Parnell Technologies Pty. Ltd., 

Unit 4, 476 Gardeners Rd., Alexandria, New South Wales 

2015, Australia.

522.558 

200–614 ....... Pentobarbital sodium and phenytoin sodium injectable solution.Do ................................................. Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 

54751.

522.1700 

141–559 ....... Pentosan polysulfate sodium 

injectable solution.

Anzac Animal Health, LLC, 218 

Millwell Dr., Suite B, Maryland 

Heights, MO 63043.

Dechra, Ltd., Snaygill Industrial 

Estate, Keighley Rd., Skipton, 

North Yorkshire, BD23 2RW, 

United Kingdom.

522.1704 

200–553 ....... Bacitracin, neomycin, polymyxin B 

ophthalmic ointment.

Akorn Operating Co. LLC, 5605 

Centerpoint Ct., Suite A, 

Gurnee, IL 60031.

Domes Pharma S.A., ZAC de 

Champ Lamet, 3 rue Andre 

Citroen, Pont-du-Chateau, Auvergne-Rhoˆne-Alpes, 63430, 

FRANCE.

524.154 

As provided in the regulatory text of 

this document, the animal drug 

regulations cited in table 3 are amended 

to reflect these actions. 

IV. Change of Sponsor Address 

Heska Corp., 1825 Sharp Point Dr., 

Fort Collins, CO 80525 has informed 

FDA that it has changed its address to 

3760 Rocky Mountain Ave., Loveland, 

CO 80538–7084. The entries in 

§ 510.600(c) are amended to reflect this 

action. 

V. Technical Amendments 

FDA is making the following 

amendments to improve the accuracy of 

the animal drug regulations. 

• 21 CFR 510.600 is amended to 

reflect sponsors of approved 

applications by adding entries for 

Domes Pharma S.A., Genus 

Lifesciences, Inc., and Noble Pharma, 

LLC, by revising the entry for Heska 

Corp., and by removing the entries for 

Jurox Pty. Ltd. and Oasmia 

Pharmaceutical AB. 

• 21 CFR 520.23 is amended to reflect 

approved strengths of acepromazine 

maleate tablets for dogs and cats. 

• 21 CFR 522.460 is amended to 

reflect current labeling for cloprostenol 

injectable solution for use in cattle. 

• 21 CFR 522.2640 is amended to 

reflect the approved strengths of generic 

tylosin injectable solutions. 

• 21 CFR 558.330 is amended to 

reflect the sponsors of drugs approved 

for use in combination medicated feeds 

containing lubebegron and monensin. 

• 21 CFR 558.355 is amended to 

reflect the classes of pasture cattle 

approved for use of a monensin freechoice block. 

• 21 CFR 558.625 is amended to 

reflect the sponsors of drugs approved 

for use in combination medicated feeds 

containing lubebegron, monensin, and 

tylosin. 

VI. Legal Authority 

This final rule is issued under section 

512(i) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

360b(i)). Although deemed a rule 

pursuant to the FD&C Act, this 

document does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a ‘‘rule of particular applicability’’ 

and is not subject to the congressional 

review requirements in 5 U.S.C. 801– 

808. Likewise, this is not a rule subject 

to Executive Order 12866. 

List of Subjects 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 516 

Administrative practice and 

procedure, Animal drugs, Confidential 

business information, Reporting and 

recordkeeping requirements. 

21 CFR Parts 520, 522, and 524 

Animal drugs. 

21 CFR Part 558 

Animal drugs, Animal feeds. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 510, 

516, 520, 522, 524, and 558 are 

amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for part 510 

continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), add entries for ‘‘Domes 

Pharma S.A.’’, ‘‘Genus Lifesciences, 

Inc.’’, and ‘‘Noble Pharma, LLC’’; revise 

the entry for ‘‘Heska Corp.’’; and remove 

the entries for ‘‘Jurox Pty. Ltd.’’ and 

‘‘Oasmia Pharmaceutical AB’’. 

■ 3. In the table in paragraph (c)(2), 

remove the entries for ‘‘049480’’ and 

‘‘052818’’, revise the entry for ‘‘063604’’, 

and add entries for ‘‘064950’’, ‘‘086119’’, 

and ‘‘086189’’. 

The revisions read as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug 

labeler code 

*******

Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhoˆne-Alpes, 63430, 

FRANCE ..................................................................................................................................................................................... 086189 


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Firm name and address Drug 

labeler code 

*******

Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109 ............................................................................................ 064950 

* * * * * * * 

Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538–7084 ....................................................................................... 063604 

* * * * * * * 

Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751 ................................................................................................... 086119 

* * * * * * * 

(2) * * * 

Drug 

labeler code Firm name and address 

*******

063604 ............. Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538–7084. 

*******

064950 ............. Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109. 

*******

086119 ............. Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751. 

*******

086189 ............. Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhoˆne-Alpes, 63430, 

FRANCE. 

* * * * * * * 

PART 516—NEW ANIMAL DRUGS FOR 

MINOR USE AND MINOR SPECIES 

■ 3. The authority citation for part 516 

continues to read as follows: 

Authority: 21 U.S.C. 360ccc–1, 360ccc–2, 

371. 

§ 516.1684 [Removed] 

■ 4. Remove § 516.1684. 

■ 5. Add § 516.1760 to subchapter E to 

read as follows: 

§ 516.1760 Phenobarbital. 

(a) Specifications. Each tablet 

contains 16.2, 32.4, 64.8, or 97.2 

milligrams (mg) phenobarbital. 

(b) Sponsor. See No. 064950 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use—(1) Amount. 

Administer phenobarbital as tablets 

given orally twice a day at the minimum 

dosage of 2.5 mg per kilogram of body 

weight (mg/kg) and may be titrated to 

effect to a maximum dosage of 5 mg/kg. 

The dosage of phenobarbital tablets 

should be adjusted based on monitoring 

the clinical response of the individual 

patient. 

(2) Indications for use. For the control 

of seizures associated with idiopathic 

epilepsy in dogs. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. It is a violation 

of Federal law to use this product other 

than as directed in the labeling. 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 6. The authority citation for part 520 

continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 7. In § 520.23, revise paragraphs (a) 

and (b) to read as follows: 

§ 520.23 Acepromazine. 

(a) Specifications. Each tablet 

contains 10 or 25 milligrams (mg) 

acepromazine maleate. 

(b) Sponsors. See Nos. 000010 and 

086117 in § 510.600(c) of this chapter. 

* * * * * 

■ 8. Add § 520.35 to read as follows: 

§ 520.35 Afoxolaner, moxidectin, and 

pyrantel. 

(a) Specifications. Each chewable 

tablet contains 9.375 milligrams (mg) 

afoxolaner, 45 micrograms (mcg) 

moxidectin, and 18.75 mg pyrantel; 

18.75 mg afoxolaner, 90 mcg 

moxidectin, and 37.5 mg pyrantel; 37.5 

mg afoxolaner, 180 mcg moxidectin, and 

75 mg pyrantel; 75 mg afoxolaner, 360 

mcg moxidectin, and 150 mg pyrantel; 

or 150 mg afoxolaner, 720 mcg 

moxidectin, and 300 mg pyrantel. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use—(1) Amount. 

Administer orally once a month at the 

minimum dose of 1.14 mg/lb (2.5 mg/ 

kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) 

moxidectin, and 2.27 mg/lb (5.0 mg/kg) 

pyrantel. For heartworm disease 

prevention, give once monthly for at 

least 6 months after last exposure to 

mosquitoes. 

(2) Indications for use in dogs. For the 

prevention of heartworm disease caused 

by Dirofilaria immitis and for the 

treatment and control of adult 

hookworm (Ancylostoma caninum, 

Ancylostoma braziliense, and Uncinaria 

stenocephala) and roundworm 

(Toxocara canis and Toxascaris 

leonina) infections. Kills adult fleas and 

is indicated for the treatment and 

prevention of flea infestations 

(Ctenocephalides felis) and the 

treatment and control of Ixodes 

scapularis (black-legged tick), 

Rhipicephalus sanguineus (brown dog 

tick), Dermacentor variabilis (American 

dog tick), and Amblyomma americanum 

(lone star tick) infestations for 1 month 

in dogs and puppies 8 weeks of age and 

older, weighing 4 pounds of body 

weight or greater. 


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(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

§ 520.928 [Amended] 

■ 9. In § 520.928, in paragraph (b)(1), 

remove ‘‘Nos. 000010, 055246, and 

055529’’ and in its place add ‘‘Nos. 

000010, 013744, 055246, 055529, and 

086101’’. 

§ 520.1044a [Amended] 

■ 10. In § 520.1044a, in paragraph (b), 

remove ‘‘Nos. 000061 and 054925’’ and 

in its place add ‘‘No. 000061’’. 

■ 11. In § 520.1195, revise paragraph 

(b)(1) to read as follows: 

§ 520.1195 Ivermectin liquid. 

* * * * * 

(b) * * * 

(1) Nos. 058005 and 058198 for use of 

product described in paragraph (a)(1) of 

this section as in paragraphs (e)(1)(i), 

(e)(1)(ii)(A), and (e)(1)(iii) of this 

section. 

* * * * * 

■ 12. In § 520.1263b, revise paragraphs 

(b)(2) and (d)(1)(iii) to read as follows: 

§ 520.1263b Lincomycin powder. 

* * * * * 

(b) * * * 

(2) Nos. 016592 and 076475 for use as 

in paragraphs (d)(1) and (2) of this 

section. 

* * * * * 

(d) * * * 

(1) * * * 

(iii) Limitations. Discard medicated 

drinking water if not used within 2 

days. Prepare fresh stock solution daily. 

Do not use for more than 10 days. If 

clinical signs of disease have not 

improved within 6 days, discontinue 

treatment and reevaluate diagnosis. The 

safety of lincomycin has not been 

demonstrated in pregnant swine or 

swine intended for breeding. Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

* * * * * 

§ 520.1484 [Amended] 

■ 13. In § 520.1484, in paragraph (b)(1), 

remove ‘‘Nos. 054771 and 054925’’ and 

in its place add ‘‘No. 054771’’; and 

remove paragraph (b)(4). 

■ 14. Add § 520.2654 to read as follows: 

§ 520.2654 Velagliflozin. 

(a) Specifications. Each milliliter of 

solution contains 15 milligrams (mg) 

velagliflozin. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use—(1) Amount. 

Administer orally 0.45 mg per pound of 

body weight (1 mg per kilogram) 

velagliflozin once daily. 

(2) Indications for use. To improve 

glycemic control in otherwise healthy 

cats with diabetes mellitus not 

previously treated with insulin. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 15. The authority citation for part 522 

continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 522.52 [Amended] 

■ 16. In § 522.52, in paragraph (b), 

remove ‘‘049480’’ and in its place add 

‘‘054771’’. 

■ 17. In § 522.147, revise paragraphs (b), 

(c)(1), and (2) to read as follows: 

§ 522.147 Atipamezole. 

* * * * * 

(b) Sponsors. See Nos. 015914, 

052483, and 069043 in § 510.600(c) of 

this chapter. 

(c) * * * 

(1) Amount. Administer 3,750 mcg/m2

intramuscularly for the reversal of 

intravenous dexmedetomidine 

hydrochloride or medetomidine 

hydrochloride and 5,000 mcg/m2

intramuscularly for the reversal of 

intramuscular dexmedetomidine 

hydrochloride or medetomidine 

hydrochloride. 

(2) Indications for use. For the 

reversal of the sedative and analgesic 

effects of dexmedetomidine 

hydrochloride and medetomidine 

hydrochloride. 

* * * * * 

■ 18. In § 522.460, revise paragraphs (b) 

and (c) to read as follows: 

§ 522.460 Cloprostenol. 

* * * * * 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter. 

(1) No. 000061 for use of product 

described in paragraph (a)(1) of this 

section as in paragraphs (c)(1)(i) and 

(c)(2) of this section. 

(2) No. 000061 for use of product 

described in paragraph (a)(2) as in 

paragraphs (c)(1)(ii) through (viii) and 

(c)(2) of this section. 

(3) No. 068504 for use of product 

described in paragraph (a)(2) as in 

paragraphs (c)(1)(ii) through (vii), 

(c)(1)(ix), and (c)(2) of this section. 

(c) Conditions of use in cattle—(1) 

Amount and indications for use. 

(i) Administer 375 mg by 

intramuscular injection to induce 

abortion in pregnant feedlot heifers from 

1 week after mating until 41⁄2 months of 

gestation. 

(ii) Administer 500 mg by 

intramuscular injection for unobserved 

or non-detected estrus in beef cows, 

lactating dairy cows, and replacement 

beef and dairy heifers. 

(iii) Administer 500 mg by 

intramuscular injection for treatment of 

pyometra or chronic endometritis in 

beef cows, lactating dairy cows, and 

replacement beef and dairy heifers. 

(iv) Administer 500 mg by 

intramuscular injection for treatment of 

mummified fetus in beef cows, lactating 

dairy cows, and replacement beef and 

dairy heifers. 

(v) Administer 500 mg by 

intramuscular injection for treatment of 

luteal cysts in beef cows, lactating dairy 

cows, and replacement beef and dairy 

heifers. 

(vi) Administer 500 mg by 

intramuscular injection for abortion of 

beef cows, lactating dairy cows, and 

replacement beef and dairy heifers from 

1 week after mating until 5 months of 

gestation. Not for use in heifers placed 

in feedlots. 

(vii) Administer 500 mg by 

intramuscular injection as a single 

injection regimen or double injection 

regimen with a second injection 11 days 

after the first injection, for estrus 

synchronization in beef cows, lactating 

dairy cows, and replacement beef and 

dairy heifers. 

(viii) For use with gonadorelin acetate 

to synchronize estrous cycles to allow 

for fixed time artificial insemination 

(FTAI) in lactating dairy cows: 

administer to each cow 86 mg 

gonadorelin by intramuscular injection, 

followed 6 to 8 days later by 500 mg 

cloprostenol by intramuscular injection, 

followed 30 to 72 hours later by 86 mg 

gonadorelin by intramuscular injection. 

Gonadorelin acetate as provided in 

§ 522.1077(a)(1) of this chapter. 

(ix) For use with gonadorelin to 

synchronize estrous cycles to allow for 

FTAI in lactating dairy cows: administer 

to each cow by intramuscular injection, 

followed 6 to 8 days later by 500 mg 

cloprostenol by intramuscular injection, 

followed 30 to 72 hours later by 

gonadorelin by intramuscular injection. 

Gonadorelin as provided in 

§ 522.1077(a)(1) through (3) of this 

chapter. 

(2) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

§ 522.540 [Amended] 

■ 19. In § 522.540, in paragraph 

(a)(2)(ii), remove ‘‘Sponsors. See Nos. 


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054925 and 058005’’ and in its place 

add ‘‘No. 058005’’. 

§ 522.558 [Amended] 

■ 20. In § 522.558, in paragraph (b)(1), 

remove ‘‘Nos. 017033, 059399, and 

086117’’ and in its place add ‘‘Nos. 

017033, 068504, 069043, and 086117’’. 

§ 522.1700 [Amended] 

■ 21. In § 522.1700, in paragraph (b), 

remove ‘‘059399’’ and in its place add 

‘‘086119’’. 

§ 522.1704 [Amended] 

■ 22. In § 522.1704, in paragraph (b), 

remove ‘‘086073’’ and in its place add 

‘‘043264’’. 

■ 23. In § 522.2640, revise paragraphs 

(b)(1) and (2) to read as follows: 

§ 522.2640 Tylosin. 

* * * * * 

(b) * * * 

(1) Nos. 016592 and 058198 for use of 

50- or 200-mg/mL solutions as in 

paragraph (e) of this section. 

(2) No. 061133 for use of a 200-mg/mL 

solution as in paragraphs (e)(1) and (2) 

of this section. 

* * * * * 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 24. The authority citation for part 524 

continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 524.154 [Amended] 

■ 25. In § 524.154, in paragraph (b)(2), 

remove ‘‘059399’’ and in its place add 

‘‘086189’’. 

§ 524.1193 [Amended] 

■ 26. In § 524.1193, in paragraph (b)(2), 

remove ‘‘Nos. 016592 and 054925’’ and 

in its place add ‘‘No. 016592’’. 

■ 27. In § 524.1600a, revise paragraph 

(b) to read as follows: 

§ 524.1600a Nystatin, neomycin, 

thiostrepton, and triamcinolone ointment. 

* * * * * 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter: 

(1) For petrolatum base ointments: 

Nos. 025463 and 054771; or 

(2) For vanishing cream base 

ointments: Nos. 025463 and 054771. 

* * * * * 

§ 524.2483 [Removed] 

■ 28. Remove § 524.2483. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 29. The authority citation for part 558 

continues to read as follows: 

Authority: 21 U.S.C. 354, 360b, 360ccc, 

360ccc–1, 371. 

■ 30. In § 558.330, revise paragraphs 

(d)(1)(ii) and (iii) and (d)(2)(i) and (ii) to 

read as follows: 

§ 558.330 Lubabegron. 

* * * * * 

(d) * * * 

(1) * * * 

Lubabegron 

fumarate in 

grams/ton 

Combination 

in grams/ton Indications for use Limitations Sponsor 

*******

(ii) 1.25 to 4.54 ...... Monensin, 5 to 40 Beef steers and 

heifers fed in 

confinement for 

slaughter: for reduction of ammonia gas emissions per pound 

of live weight 

and hot carcass 

weight and for 

improved feed 

efficiency during 

the last 14 to 91 

days on feed.

Feed continuously as the sole ration to provide 13 to 90 

mg lubabegron/head/day and 50 to 480 mg monensin/ 

head/day during the last 14 to 91 days on feed. No additional improvement in feed efficiency has been shown 

from feeding monensin at levels greater than 30 g/ton 

(360 mg monensin/head/day). A decrease in dry matter 

intake may be noticed in some animals receiving 

lubabegron. Lubabegron has not been approved for use 

in breeding animals because safety and effectiveness 

have not been evaluated in these animals. Do not allow 

horses or other equines access to feed containing 

lubabegron and monensin. Ingestion of monensin by 

horses has been fatal. Monensin medicated cattle and 

goat feeds are safe for use in cattle and goats only. 

Consumption by unapproved species may result in toxic 

reactions. Feeding undiluted or mixing errors resulting in 

high concentrations of monensin has been fatal to cattle 

and could be fatal to goats. Must be thoroughly mixed 

in feeds before use. Do not exceed the levels of 

monensin recommended in the feeding directions, as 

reduced average daily gains may result. If feed refusals 

containing monensin are fed to other groups of cattle, 

the concentration of monensin in the refusals and 

amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for 

preruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in 

§ 558.355(d) of this chapter. Lubabegron fumarate as 

provided by No. 058198, monensin as provided by No. 

016592 or 058198 in § 510.600(c) of this chapter.

016592, 058198 


lotter on DSK11XQN23PROD with RULES1
84702 Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations 

Lubabegron 

fumarate in 

grams/ton 

Combination 

in grams/ton Indications for use Limitations Sponsor 

(iii) 1.25 to 4.54 ..... Monensin, 10 to 40 Beef steers and 

heifers fed in 

confinement for 

slaughter: for reduction of ammonia gas emissions per pound 

of live weight 

and hot carcass 

weight; and for 

prevention and 

control of coccidiosis due to 

Eimeria bovis 

and E. zuernii 

during the last 

14 to 91 days on 

feed.

Feed continuously as the sole ration to provide 13 to 90 

mg lubabegron/head/day and 0.14 to 0.42 mg 

monensin/lb body weight per day, depending upon severity of coccidiosis challenge, during the last 14 to 91 

days on feed. A decrease in dry matter intake may be 

noticed in some animals receiving lubabegron. 

Lubabegron has not been approved for use in breeding 

animals because safety and effectiveness have not 

been evaluated in these animals. Do not allow horses 

or other equines access to feed containing lubabegron 

and monensin. Ingestion of monensin by horses has 

been fatal. Monensin medicated cattle and goat feeds 

are safe for use in cattle and goats only. Consumption 

by unapproved species may result in toxic reactions. 

Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and 

could be fatal to goats. Must be thoroughly mixed in 

feeds before use. Do not exceed the levels of monensin 

recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing 

monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent 

monensin overdosing. A withdrawal period has not been 

established for this product for preruminating calves. Do 

not use in calves to be processed for veal. See special 

labeling considerations in § 558.355(d) of this chapter. 

Lubabegron fumarate as provided by No. 058198, 

monensin as provided by No. 016592 or 058198 in 

§ 510.600(c) of this chapter.

016592, 058198 

(2) * * * 

(i) Monensin as in § 558.355. 

(ii) Tylosin in § 558.625. 

■ 31. In § 558.355, revise paragraph 

(f)(4)(iv) to read as follows: 

§ 558.355 Monensin. 

* * * * * 

(f) * * * 

(4) * * * 

Monensin amount Indications for use Limitations Sponsor 

*******

(iv) 400 mg per pound of block Growing beef steers and heifers on pasture (stocker, 

feeder, and slaughter) and 

beef replacement heifers): 

for increased rate of weight 

gain.

Provide 50 to 200 mg of monensin (2 to 8 ounces of block) 

per head per day, in at least one block per five head of 

cattle. Feed blocks continuously. Do not feed salt of mineral supplements in addition to this block. Discontinue 

feeding if block consumption falls below 2 ounces or rises 

above 8 ounces daily. See paragraph (d)(10)(i) of this section..

086113 

* * * * * * * 

* * * * * ■ 32. In § 558.625, revise paragraphs 

(e)(2)(vii) and (viii) to read as follows: 

§ 558.625 Tylosin. 

* * * * * 

(e) * * * 

(2) * * * 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations 84703 

Tylosin grams/ton Combination in 

grams/ton Indications for use Limitations Sponsor 

*******

(vii) 8 to 10 ............ Monensin, 5 to 40 

plus lubabegron 

fumarate, 1.25 to 

4.54.

Beef steers and 

heifers fed in 

confinement for 

slaughter: for reduction of ammonia gas emissions per pound 

of live weight 

and hot carcass 

weight; for reduction of incidence of liver 

abscesses associated with 

Fusobacterium 

necrophorum 

and 

Arcanobacterium 

pyogenes and 

for improved 

feed efficiency 

during the last 

14 to 91 days on 

feed.

Feed continuously as sole ration to provide 13 to 90 mg 

lubabegron/head/day, 50 to 480 mg monensin/head/ 

day, and 60 to 90 mg tylosin/head/day during the last 

14 to 91 days on feed. No additional improvement in 

feed efficiency has been shown from feeding monensin 

at levels greater than 30 g/ton (360 mg monensin/head/ 

day). A decrease in dry matter intake may be noticed in 

some animals receiving lubabegron. Lubabegron has 

not been approved for use in breeding animals because 

safety and effectiveness have not been evaluated in 

these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. 

Monensin medicated cattle and goat feeds are safe for 

use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding 

undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be 

fatal to goats. Must be thoroughly mixed in feeds before 

use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing 

monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent 

monensin overdosing. A withdrawal period has not been 

established for this product for preruminating calves. Do 

not use in calves to be processed for veal. See special 

labeling considerations in § 558.355(d) of this chapter. 

Tylosin as provided by No. 016592 or 058198, 

monensin as provided by No. 016592 or 058198, 

lubabegron fumarate as provided by No. 058198 in 

§ 510.600(c) of this chapter.

016592, 058198 

(viii) 8 to 10 ........... Monensin, 10 to 40 

plus lubabegron 

fumarate, 1.25 to 

4.54.

Beef steers and 

heifers fed in 

confinement for 

slaughter: for reduction of ammonia gas emissions per pound 

of live weight 

and hot carcass 

weight, for reduction of incidence of liver 

abscesses associated with 

Fusobacterium 

necrophorum 

and 

Arcanobacterium 

pyogenes and 

for prevention 

and control of 

coccidiosis due 

to Eimeria bovis 

and E. zuernii 

during the last 

14 to 91 days on 

feed.

Feed continuously as sole ration to provide 13 to 90 mg 

lubabegron/head/day, 0.14 to 0.42 mg monensin/lb 

body weight per day, depending upon severity of coccidiosis challenge, up to 480 mg/head/day, and 60 to 90 

mg tylosin/head/day during the last 14 to 91 days on 

feed. A decrease in dry matter intake may be noticed in 

some animals receiving lubabegron. Lubabegron has 

not been approved for use in breeding animals because 

safety and effectiveness have not been evaluated in 

these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. 

Monensin medicated cattle and goat feeds are safe for 

use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding 

undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be 

fatal to goats. Must be thoroughly mixed in feeds before 

use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing 

monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent 

monensin overdosing. A withdrawal period has not been 

established for this product for preruminating calves. Do 

not use in calves to be processed for veal. See special 

labeling considerations in § 558.355(d) of this chapter. 

Tylosin as provided by No. 016592 or 058198, 

monensin as provided by No. 016592 or 058198, 

lubabegron fumarate as provided by No. 058198 in 

§ 510.600(c) of this chapter.

016592, 058198 

* * * * * * * 


lotter on DSK11XQN23PROD with RULES1
84704 Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations 

* * * * * 

Dated: November 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26545 Filed 12–5–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

36 CFR Parts 212, 214, and 251 

RIN 0596–AD54 

Travel Management; Administration of 

the Forest Transportation System; 

Postdecisional Administrative Review 

Process for Occupancy or Use of 

National Forest System Lands and 

Resources; Land Uses; Special Uses 

AGENCY: Forest Service, USDA. 

ACTION: Final rule. 

SUMMARY: The United States Department 

of Agriculture, Forest Service (Forest 

Service or Agency) is making purely 

technical, clarifying revisions to its 

existing regulations governing 

administration of the forest 

transportation system, administrative 

appeal of certain written decisions 

pertaining to written authorizations for 

occupancy or use of National Forest 

System (NFS) lands and resources, and 

issuance and administration of special 

use authorizations for use and 

occupancy of NFS lands. The purely 

technical, clarifying revisions update 

citations and enhance consistency of the 

existing regulations with governing 

statutes. 

DATES: This rule is effective December 6, 

2023. 

ADDRESSES: Information on this final 

rule may be obtained via written request 

addressed to the Director, Lands, 

Minerals, and Geology Management, 

USDA Forest Service, 201 14th Street 

NW, Washington, DC 20250–1124 or by 

email to SM.FS.WO_LandStaff@

usda.gov. 

FOR FURTHER INFORMATION CONTACT: 

Mark Chandler, Realty Specialist, (202) 

205–1117 or mark.chandler@usda.gov. 

Individuals who use telecommunication 

devices for the hearing impaired may 

call the Federal Relay Service at (800) 

877–8339 between 8:00 a.m. and 5:00 

p.m., Eastern Time, Monday through 

Friday. 

SUPPLEMENTARY INFORMATION: This final 

rule makes purely technical, clarifying 

revisions to the Agency’s existing 

regulations at 36 CFR 212.8, 214.4, 

251.50, 251.51, 251.53, 251.54, 251.55, 

251.57, 251.58, 251.59, 251.60, 251.64, 

and 251.124 governing administration of 

the forest transportation system, 

administrative appeal of certain written 

decisions pertaining to written 

authorizations for occupancy or use of 

NFS lands and resources, and issuance 

and administration of special use 

authorizations for use and occupancy of 

NFS lands. The purely technical, 

clarifying revisions update citations and 

enhance consistency of the existing 

regulations with governing statutes. 

These purely technical, clarifying 

revisions do not formulate standards, 

criteria, or guidelines applicable to 

Forest Service programs and therefore 

do not require public notice and 

opportunity to comment under section 

14(a) of the Forest and Rangeland 

Renewable Resources Planning Act of 

1974 (16 U.S.C. 1612(a)). 

36 CFR Part 212, Subpart A 

The Department is revising text in 

§ 212.8(d)(5)(i) to track revisions being 

made to § 251.60(a)(2)(i) and to provide 

that a formal adjudicatory hearing is 

required for revocation for nonuse of an 

easement issued under the National 

Forest Roads and Trails Act (FRTA). 

36 CFR Part 214 

The Department is revising 

§ 214.4(c)(1)(i) to provide that 

suspension or revocation of permits as 

well as easements issued under the 

Mineral Leasing Act (MLA) and 

revocation for nonuse of an easement 

issued under FRTA are not subject to 

administrative appeal under 36 CFR 

part 214. In contrast to the Federal Land 

Policy and Management Act (FLPMA) 

addressed in 36 CFR 251.53(l), the MLA 

addressed in 36 CFR 251.53(e) requires 

a formal adjudicatory proceeding for 

suspension or revocation of permits as 

well as easements (30 U.S.C. 

185(o)(1)(C)). Therefore, suspension or 

revocation of permits as well as 

easements issued under the MLA must 

be exempt from the informal 

administrative appeal process under 36 

CFR part 214. FRTA provides for a 

formal hearing for revocation of an 

easement for nonuse (16 U.S.C. 534). 

36 CFR Part 251, Subpart B 

§ 251.50 

The Department is removing 

paragraph (c)(3) of § 251.50, which 

requires a special use authorization for 

a noncommercial recreational activity if 

required by an order issued under 36 

CFR part 261, subpart B, or by a 

regulation issued under 36 CFR part 

261, subpart C. There is no basis for 

issuance of such an order under 36 CFR 

part 261, subpart B. Moreover, there is 

no need for issuance of such an order 

or regulation because the Forest Service 

has the authority to require a 

noncommercial special recreation 

permit under the Federal Lands 

Recreation Enhancement Act and its 

implementing directives in Forest 

Service Handbook (FSH) 2309.13, 

Chapter 30. 

§ 251.51 

The Department is revising the 

definitions for ‘‘outfitting’’ and 

‘‘guiding’’ by replacing the phrase 

‘‘pecuniary remuneration’’ with the 

word ‘‘monetary.’’ The revised language 

is more contemporary and easier to 

understand. 

§ 251.53 

The Department is revising § 251.53(a) 

by changing the phrase ‘‘group events’’ 

to ‘‘noncommercial group use’’ and 

deleting the phrase ‘‘and distribution of 

noncommercial printed materials’’ for 

authorizations issued under the Organic 

Administration Act (16 U.S.C. 551). The 

term of art per the definitions for special 

uses in 36 CFR 251.51 is 

‘‘noncommercial group use.’’ The 

distribution of noncommercial printed 

materials does not require a special use 

authorization under 36 CFR 251.50(c). 

The Department is adding paragraph 

(o) to § 251.53 to include the Forest 

Service’s authority under section 111 of 

the National Historic Preservation Act of 

1966 (54 U.S.C. 306121) to issue leases 

for Federally owned historic properties 

on NFS lands. 

§ 251.54 

The Department is revising 

§ 251.54(d) through (g) to use 

appropriate terminology when referring 

to a proponent or a proposal and to 

enhance clarity. 

The Department is revising 

§ 251.54(e)(1)(iv), which precludes 

consideration of proposals for a 

permanent use and occupancy of NFS 

lands, to add an exception for 

permanent easements issued under 

FRTA (16 U.S.C. 533). 

The Department is revising 

§ 251.54(f)(1)(i) regarding who may 

apply for an oil or gas pipeline right-ofway authorization for greater 

consistency with the MLA (30 U.S.C. 

181). 

The Department is revising 

§ 251.54(g)(3)(iii) to replace the citation 

to 36 CFR part 215 with a citation to 36 

CFR part 218. The postdecisional 

administrative appeal process in 36 CFR 

part 215 has been replaced with the 

predecisional objection process in 36 

CFR part 218. 


lotter on DSK11XQN23PROD with RULES1